Heart valve prosthesis and methods of manufacture and use

Abstract

A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

What is claimed is: 
     
       1. A valve prosthesis comprising:
 a valve body comprising three leaflets, each leaflet including: 
 a body, 
 a free edge, and 
 enlarged lateral ends at either end of the free edge, 
 wherein adjacent enlarged lateral ends of adjoining leaflets are sewn together to form commissures; and 
 a self-expanding frame, the frame having an inflow section having a first row of cells in a circumferentially repeating pattern, an outflow section having a second row of cells in a circumferentially repeating pattern and including an eyelet, and a middle region between the inflow section and the outflow section, wherein the middle region is configured to avoid blocking blood flow to the coronary arteries when the frame is implanted in a body, wherein the area of individual cells in the first row of cells is less than the area of individual cells in the second row of cells, 
 wherein the frame supports the valve body, wherein the frame has a longitudinal axis, wherein the frame has a contracted delivery configuration and an expanded deployed configuration, 
 wherein, when the frame is in the expanded deployed configuration, the outflow section diameter is larger than the inflow section diameter, 
 wherein each commissure spans a cell of the frame, 
 wherein a plurality of cells of the frame are positioned between the cells spanned by commissures, 
 wherein each free edge is suspended from the leaflet's commissures to define coaptation edges and a center of coaptation, and 
 wherein the length of each free edge forms a substantially continuous curve extending downwardly between the respective commissures so that the free edges of the leaflets generally define the shape of catenaries to substantially uniformly distribute loads over the leaflets. 
 
     
     
       2. The valve prosthesis of  claim 1 , wherein the leaflets comprise porcine, bovine, equine or other mammalian pericardial tissue, synthetic material, or polymeric material. 
     
     
       3. The valve prosthesis of  claim 1 , wherein the leaflets are sewn to a skirt at joints, wherein the skirt is sewn to the inflow section of the frame, and wherein the joints are affixed to the frame to evenly distribute forces through the valve body to the frame. 
     
     
       4. The valve prosthesis of  claim 3 , wherein the frame further comprises a cell pattern that defines a contour configured to support the joints. 
     
     
       5. The valve prosthesis of  claim 1 , wherein the frame comprises a cell pattern defined by unequal length zig-zags. 
     
     
       6. The valve prosthesis of  claim 1 , wherein the commissures are affixed to the frame at a location proximal of the center of coaptation. 
     
     
       7. The valve prosthesis of  claim 1 , wherein the adjacent enlarged lateral ends of adjoining leaflets span an entire area of a cell. 
     
     
       8. The valve prosthesis of  claim 1 , wherein the inflow section includes a first row of cells, wherein the outflow section includes a second row of cells, and wherein the number of cells in the first row of cells is equal to the number of cells in the second row of cells. 
     
     
       9. The valve prosthesis of  claim 1 , wherein the middle region and the outflow section comprise a cell pattern that provides a pre-determined radius of curvature for a transition from the middle region to the outflow section when the frame is in the expanded deployed configuration. 
     
     
       10. The valve prosthesis of  claim 1 , wherein a diameter of a constriction region is less than the inflow section diameter. 
     
     
       11. The valve prosthesis of  claim 1 , wherein the outflow section includes exactly three eyelets. 
     
     
       12. The valve prosthesis of  claim 1 , wherein the frame includes four rows of cells. 
     
     
       13. A valve prosthesis comprising:
 a valve body comprising three leaflets, each leaflet including a body, a free edge, and enlarged lateral ends at either end of the free edge, adjacent enlarged lateral ends of adjoining leaflets being sewn together to form commissures; and 
 a self-expanding frame comprising a plurality of cells, the frame having an inflow section, an outflow section, and a middle region between the inflow section and the outflow section, wherein the middle region is configured to avoid blocking blood flow to the coronary arteries when the frame is implanted in a body, 
 wherein the frame supports the valve body, wherein the frame has a longitudinal axis, wherein the frame has a contracted delivery configuration and an expanded deployed configuration, 
 wherein, when the frame is in the expanded deployed configuration, the outflow section has a larger diameter than the inflow section, 
 wherein each commissure is configured to span a cell of the frame to distribute force within the commissures and to the frame, and wherein a plurality of cells of the frame are positioned between the cells spanned by commissures, 
 wherein each free edge is suspended from the leaflet's commissures to define coaptation edges and a center of coaptation, and 
 wherein the length of each free edge forms a substantially continuous curve extending downwardly between the respective commissures so that the free edges of the leaflets generally define the shape of catenaries to substantially uniformly distribute loads over the leaflets.